The following data is part of a premarket notification filed by Lab-interlink, Inc. with the FDA for Automated Workcell Control Software.
| Device ID | K010500 |
| 510k Number | K010500 |
| Device Name: | AUTOMATED WORKCELL CONTROL SOFTWARE |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | LAB-INTERLINK, INC. 1011 SOUTH SADDLE CREEK RD. Omaha, NE 68106 |
| Contact | Deborah S Kipp |
| Correspondent | Deborah S Kipp LAB-INTERLINK, INC. 1011 SOUTH SADDLE CREEK RD. Omaha, NE 68106 |
| Product Code | JJE |
| Subsequent Product Code | GKP |
| Subsequent Product Code | GKZ |
| Subsequent Product Code | KHO |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-21 |
| Decision Date | 2001-08-01 |